A Study of the Effects of a New Antidepressant Treatment (GSK561679) in Females With Major Depressive Disorder

NCT00733980 | Completed Phase 2 Results

• 1 other identifier: 106139
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 18

Brief Summary

This six-week study will evaluate the efficacy, safety and tolerability of GSK561679 compared to placebo in female subjects with major depressive disorder

Conditions

Depressive Disorder, Major

Keywords

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• Change From Randomization to the End of Treatment Phase (Week 6) in the Bech Melancholia Subscale (Bech) (Items 1, 2, 7, 8, 10 and 13) From the Hamilton Rating Scale for Depression (HamD17).

  The Bech Melancholia Sub-scale is extracted from the HAMD-17 and is comprised of the following 6 items: Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic, and Somatic Symptoms General. The items Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic are scored on a 5-point scale from 0 to 4 except for Somatic Symptoms General which is scored on a 3-point scale from 0 to 2 where the higher scores reflecting greater severity. The Bech Melancholia Scale total score is calculated by summing the individual response scores. The highest possible score is 22 (indicative of greater severity) and the lowest possible score is 0 (indicating absence of symptoms). Change from randomization was defined as the post-baseline value minus the value at randomization. Randomization was defined as Week 0.

  Randomization (Week 0) and Week 6

Secondary Outcomes (18)

• Change From Randomization to Weeks 1, 2, and 4 in the Bech Melancholia Scale Score.

  Randomization (Week 0) and Week 1, 2 and 4

• Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Anxiety Scale (HAM A)

  Randomization (Week 0) and Week 1, 2, 4 and Week 6

• Change From Randomization to Weeks 1, 2, 3, 4, and 6 in the Inventory of Depressive Symptomatology-Self- Report (IDS-SR) Total Score.

  Randomization (Week 0) and Week 1, 2, 3,4 and Week 6

• Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Rating Scale for Depression (HAMD-17)

  Randomization (Week 0) and Week 1, 2, 4 and Week 6

• Percentage HAMD-17 Responders at Weeks 1, 2, 4, and 6.

  Weeks 1, 2, 4, and 6.

Study Arms (2)

GSK561679 arm

EXPERIMENTAL

Double blind GSK561679

Drug: GSK561679

placebo arm

PLACEBO COMPARATOR

Double blind placebo

Other: Placebo

Interventions

GSK561679 DRUG

GSK561679

GSK561679 arm

Placebo OTHER

Placebo

placebo arm

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female outpatients aged 25-64 years, inclusive.
• Subjects must have the ability to comprehend the consent form, and provide informed consent.
• Subject currently meets the diagnosis for MDD (without psychotic features), single episode or recurrent, as defined in the DSM-IV-TR, diagnosed with SCID-CT (Structural Clinical Interview for DSM-IV Axis I disorders - Clinical Trials Version) as assessed \* by a physician with adequate training in psychiatry (e.g., Board Certification in psychiatry in the US or equivalent local qualification in other countries)
• Subject must, in the investigator's opinion based on clinical history, have met DSM IV-TR criteria for their current major depressive episode for at least 4 weeks but for no greater than 24 months.
• Subject has an IVRS HamD17 total score ≥ 23 at the Screening and Randomization Visits and the HAMD17 score is confirmed to be at least 20 by the Independent Efficacy Rater at the Screening and Randomization Visits.
• The subject is eligible to enter and participate in this study if she is not lactating and:
• Is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal \[defined as one year without menses\]); is surgically sterile \[via hysterectomy and/or removal of the ovaries\] or, is of child-bearing potential, has a negative pregnancy test at both screening and baseline (prior to investigational product administration), and agrees to acceptable methods of contraception.

You may not qualify if:

• Symptoms of the presenting illness which are better accounted for by another diagnosis\*; or
• A current DSM-IV-TR Axis I diagnosis of Dementia; or
• Antisocial or Borderline Personality Disorder or other current DSM-IV-TR Axis II diagnosis that would suggest unresponsiveness to pharmacotherapy or non-compliance with the protocol; or
• A current (or within 12 months prior to the Screening visit) diagnosis of anorexia nervosa or bulimia; or
• A lifetime history of Schizophrenia, Schizoaffective Disorder, or a Bipolar Disorder.
• Subject has an unstable medical disorder or a disorder that would interfere with the action, absorption, distribution, metabolism, or excretion of GSK561679 or may pose a safety concern, or interfere with the accurate assessment of safety or efficacy.
• Subject has initiated psychotherapy within one month prior to the Screening visit, or plans to initiate psychotherapy during the trial. Subjects who present with their current MDD diagnosis despite longer-term psychotherapy (i.e., greater than three months prior to the Screening visit) and who agree to maintain the same therapy schedule during the trial may be included.
• Subject has received vagus nerve stimulation, electroconvulsive therapy, or transcranial magnetic stimulation within the six months prior to the Screening visit.
• Subject has previously failed adequate therapeutic courses of pharmacotherapy for MDD (e.g., maximum-labeled/tolerated doses for ≥ 4 weeks) from two different classes of antidepressants.
• Subject, who, in the investigator's judgement, poses a homicidal or serious suicidal risk, has had any previous suicide attempt (including aborted, interrupted or ineffective attempts) or who has ever been homicidal.
• Subject has no contact with an adult on a daily basis (i.e., subjects who are not living with at least one other adult or subjects who do not have an adult who contacts them on a daily basis). This criterion only applies to sites in Canadian sites and others where this is a local requirementa.
• Subject has a positive urine test at screening for illegal drug use and/or history of substance abuse or dependence (alcohol or drugs as defined by DSM-IV TR criteria) within the past 12 months. Subject has a blood alcohol level of ≥ 15mg/dL (0.015%) at the Screening Visit. If a subject has a positive blood alcohol or positive illegal drug results, the subject is provisionally excluded and the test cannot be repeated without prior approval of the GSK medical monitor. NOTE: Subjects must be told to avoid consumption of alcoholic beverages for at least eight hours prior to the Screening Visit. The use of alcohol by subjects participating in the study is not recommended.
• Subject has any laboratory abnormality that in the investigator's judgement is considered to be clinically significant and could potentially affect subject safety or study outcome.
• Subject has a systolic blood pressure (SBP) \> 160mmHg or a diastolic blood pressure (DBP) ≥ 100 mmHg verified by repeated measurement at the Screening or Randomization visit.
• Subject is (a) currently participating in another clinical study in which the subject is or will be exposed to an investigational or non-investigational drug or device; or (b) has participated in a clinical study for an illness unrelated to depression/anxiety within the preceding month; or (c) has participated in a clinical study related to depression/anxiety within the preceding six months.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (18)

GSK Investigational Site

Cerritos, California, 90703, United States

Location

GSK Investigational Site

San Diego, California, 92108, United States

Location

GSK Investigational Site

Torrance, California, 90502, United States

Location

GSK Investigational Site

Jacksonville, Florida, 32216, United States

Location

GSK Investigational Site

Miami, Florida, 33125, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30322, United States

Location

GSK Investigational Site

Marietta, Georgia, 30060, United States

Location

GSK Investigational Site

Chicago, Illinois, 60612, United States

Location

GSK Investigational Site

Skokie, Illinois, 60076, United States

Location

GSK Investigational Site

Shreveport, Louisiana, 71104, United States

Location

GSK Investigational Site

Rockville, Maryland, 20852, United States

Location

GSK Investigational Site

Albuquerque, New Mexico, 87109, United States

Location

GSK Investigational Site

Raleigh, North Carolina, 27609, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45219-0516, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

GSK Investigational Site

Memphis, Tennessee, 38119, United States

Location

GSK Investigational Site

Brown Deer, Wisconsin, 53223, United States

Location

GSK Investigational Site

Madison, Wisconsin, 53719, United States

Location

Related Publications (1)

• GSK has concluded that it is not feasible to publish this study in a peer-reviewed scientific journal because the nature of the study is unlikely to be of interest to a journal. GSK is providing the attached study results summary with a conclusion.

  BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

NBI 77860

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2008
• First Posted: August 13, 2008
• Study Start: October 2, 2008
• Primary Completion: June 18, 2010
• Study Completion: June 18, 2010
• Last Updated: November 17, 2017
• Results First Posted: November 17, 2017

Record last verified: 2017-08

Locations

US (18)